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Nicotinell Mint Lozenge 1mg (pack of 36) |
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1 lozenge contains 1mg nicotine (corresponding to 3.072 mg bitartrate dihydrate).
Compressed lozenge
White, mint flavoured, round biconvex lozenge.
Nicotinell treatment is indicated for the relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation.
Advice and support normally improve the success rate.
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Adults and elderly
Users should stop smoking completely during treatment with Nicotinell lozenge.
Nicotinell Mint 1 mg lozenge is recommended in smokers with a medium nicotine dependency.
Nicotinell Mint 1 mg lozenge is not recommended in the case of smokers with a strong nicotine dependency.
The initial dosage should be individualised on the basis of the patients nicotine dependence. One piece of lozenge to suck when the user feels the urge to smoke.
Initially, 1 lozenge should be taken every 1-2 hours. The usual dosage is 8-12 lozenges per day. The maximum daily dose is 30 lozenges.
The optimal dosage form is selected according to the following table:
Low to moderate dependency |
Moderate to strong dependency |
Strong to very strong dependency |
Less than 20 cigarettes / day |
From 20 to 30 cigarettes / day |
Over 30 cigarettes / day |
Low dose forms are preferable
(1mg lozenge) |
Low (1mg lozenge) or high (2mg lozenge) dose forms are acceptable depending on patient characteristics and preference.
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High dose forms are preferable
(2mg lozenge) |
Low dosage forms acceptable |
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If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form.
Directions for use:
1. One lozenge to be sucked until the taste becomes strong.
2. The lozenge should then be lodged between the gum and cheek.
3. When the taste fades, sucking of the lozenge should commence again
4. The sucking routine will be adapted individually and should be repeated until the lozenge dissolves completely (about 30 minutes)
The treatment time is individual. Normally, treatment should continue for at least 3 months. After 3 months, the user should gradually reduce the number of lozenges. Treatment should be discontinued when the dose has been reduced to 1-2 lozenges per day. Use of nicotine products like Nicotinell Mint 1 mg lozenge beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the lozenge longer to avoid returning to smoking.
Counselling may help smokers to quit.
Nicotinell Mint 1 mg lozenge is sugar-free.
Children and adolescents (< 18 years)
Nicotinell lozenge should not be used by people under 18 years of age without recommendation from a physician. There is no experience in treating adolescents under the age of 18 with Nicotinell lozenge.
Concomitant use of acidic beverages such as coffee or soda may decrease the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to sucking the lozenge.
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Hypersensitivity to any excipients of the lozenge
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Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent cerebrovascular accident should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicotinell lozenges may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision.
Nicotinell lozenges should be used with caution in patients with hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, heart failure, diabetes mellitus, hyperthyroidism or pheochromocytoma and severe hepatic and/or renal impairment.
Patients should initially be encouraged to stop smoking with non-pharmacological interventions (such as counseling).
Swallowed nicotine may exacerbate symptoms in patients suffering from active oesophagitis, oral and pharyngeal inflammation, gastritis or peptic ulcer.
Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal (please see Section 4.9).
Each Nicotinell Mint 1mg lozenge contains aspartame, a source of phenylalanine equivalent to 5 mg/dose and may be harmful for people with phenylketonuria.
Because Nicotinell Mint 1mg lozenge contains maltitol (E965):
- patients with rare hereditary problems of fructose intolerance should not take this medicine.
- patients may have a mild laxative effect.
Calorific value 2.3 kcal/g maltitol.
Nicotinell Mint 1 mg lozenge contains 9.8 mg of sodium per piece.
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